UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________
`
`NUVASIVE, INC.
`Petitioner
`
`v.
`
`WARSAW ORTHOPEDIC, INC.
`Patent Owner
`
`
`Patent Number: 8,251,997 B2
`Issue Date: August 28, 2012
`
`
`Case IPR2013-00206
`
`______________________________________________________
`
`
`SECOND DECLARATION OF DR. PAUL McAFEE, M.D., M.B.A.
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`
`
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`
`
`
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
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`
`
` 1
`
`NUVASIVE 1029
`NuVasive, Inc. v. Warsaw Orthopedic, Inc.
`IPR2013-00206
`
`
`__________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________
`
`NUVASIVE, INC.
`Petitioner
`
`v.
`
`WARSAW ORTHOPEDIC, INC.
`Patent Owner
`
`
`Patent Number: 8,251,997 B2
`Issue Date: August 28, 2012
`
`
`Case IPR2013-00206
`
`______________________________________________________
`
`
`SECOND DECLARATION OF DR. PAUL McAFEE, M.D., M.B.A.
`
`
`
`
`
`
`
`
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
` 1
`
`NUVASIVE 1029
`NuVasive, Inc. v. Warsaw Orthopedic, Inc.
`IPR2013-00206
`
`
`
`I, Dr. Paul McAfee, M.D., M.B.A., of Sparks Glencoe, Maryland, declare that:
`
`I.
`
`Introduction
`
`1.
`
`On March 21, 2013 I provided an initial Declaration in this matter. I reaffirm
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`the opinions stated in that Declaration. This Second Declaration is in rebuttal to statements
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`made in the Patent Owner’s Response and the accompanying Sachs Declaration submitted
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`on December 20, 2013. I disagree with any statements and positions that contradict or are
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`inconsistent with my initial Declaration. In this Second Declaration, I will address some of
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`these errors and contradictions set forth in the Patent Owner Response and supporting
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`Sachs declaration.
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`2.
`
`I have reviewed the following documents:
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`a. In the inter partes review proceeding IPR2013-00208:
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`i. Warsaw’s Preliminary Response;
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`ii. Warsaw’s Patent Owner Response;
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`iii. Ex. 2038, Declaration of Barton L. Sachs;
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`iv. Ex. 1001, 1002, 1006, 1014, 1033-1037, 1039, 1041-1044, 1047,
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`1051-1069, 1073; and
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`v. Ex. 2001-2009, 2018, 2039, 2041, 2042, 2055.
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`b. In the inter partes review proceeding IPR2013-00206:
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`i. Warsaw’s Preliminary Response;
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`ii. Warsaw’s Patent Owner Response;
`
`
`
`1
`
`
`
` 2
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`
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`iii. Ex. 2038, Declaration of Barton L. Sachs;
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`iv. Ex. 1001, 1002, 1006, 1014, 1033-1037, 1039, 1041-1044, 1047,
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`1051-1069, 1073; and
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`v. Ex. 2001-2009, 2018, 2039, 2041, 2042, 2055.
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`I have also reviewed additional references cited in this Declaration but not included
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`in the list above. Further, I have reviewed the March 2014 Declaration of Dr. Robert E.
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`Jacobson, the March 2014 Declaration of Patrick Miles, and the March 2014 Declaration of
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`Dr. John W. Brantigan, which I was informed are to be submitted in the inter partes review
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`proceedings IPR2013-00206 and IPR2013-00208 as Exhibits 1030-1032.
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`II. Rebuttal of Dr. Sachs’ testimony regarding background
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`3.
`
`In ¶ 29 of the Sachs declaration, Dr. Sachs presents images alleged to
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`“illustrate the boundaries of a typical vertebral endplate, and indicate that the endplates are
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`distinct from the apophyseal ring.” The images presented are simplified artwork, not images
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`of actual human anatomy. The simplified artwork in ¶ 29 is generally accurate to show
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`approximate positioning of various tissue, but are not accurate for Dr. Sachs’ purpose of
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`showing “distinct” boundaries. The boundaries between the vertebral endplate, the
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`apophyseal ring, and the cortical rim are not “distinct” and in fact are often not discernible in
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`an actual human spine, and most certainly not in a typical spine of patients suffering from
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`some spinal conditions requiring a fusion surgery. In reality, the endplate and apophyseal
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`ring are confluent with one another, especially in mature adults suffering from some spinal
`
`
`
`2
`
`
`
` 3
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`
`
`conditions requiring a fusion surgery, such that the end plate includes the entire apophyseal
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`ring and more (the more central regions of cortical bone and compacted cancellous bone).
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`See Ex. 2039 at 48:9-10 (“the apophyseal ring and cortical bone are parts of the end plate”),
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`48:18-20. In fact, those of ordinary skill in the art of spine surgery and even Warsaw (the
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`Patent Owner) often refer to the apophyseal ring as merely part of the vertebral endplate,
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`not distinct from it. See, e.g., Warsaw’s U.S. Patent No. 8,613,769 (Ex. 1056) at 5:48-6:2
`
`and 17:17-22 (“the apophyseal ring of the vertebral endplates”); Warsaw’s European Patent
`
`No. EP2108341 (Ex. 1057) at para. 0075 (“the apophyseal ring of the vertebral endplate”).
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`Also, in the context of the ‘997 patent, at least the apophyseal ring and the cortical rim in the
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`area of the implant I would be destroyed and removed from the spine during the procedures
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`illustrated in FIGS. 18-24 and 29-30 of the ‘997 patent, as explained in more detail below.
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`So the simplified and undamaged vertebra drawings in ¶ 29 of the Sachs declaration are not
`
`accurate in the context of inserting the implant I in the procedure disclosed and illustrated in
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`FIGS. 29-30 and 16-23 of the ‘997 patent.
`
`4.
`
`In ¶ 30, Dr. Sachs testified that “interbody spinal fusion is one of many types
`
`of spinal fusion procedures.” I agree with this statement, and indeed it is the exact type of
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`spinal fusion procedure suggested by Jacobson, which discloses that a lumbar disc space is
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`targeted and disc material is removed and that a “fusion” can also be performed through the
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`laterally inserted cannula 11. See Jacobson (Ex. 1004) at FIGS. 6-8; col. 6, lines 9-13; First
`
`McAfee Decl. (Ex. 1001), ¶¶ 11 and 22. By the early 1990s, a spinal surgeon of ordinary
`
`
`
`3
`
`
`
` 4
`
`
`
`skill in the art reviewing the Jacobson patent would have understood that Jacobson’s
`
`express suggestion for performing a fusion through the laterally inserted cannula 11 should
`
`be implemented using an interbody implant in the targeted disc space so that the disc space
`
`would not collapse and so that bony fusion would be achieved. See March 2014 Jacobson
`
`Decl. (Ex. 1030), ¶ 10. By that time in the early 1990s, such fusion procedures were
`
`commonly performed using implants formed from bone (e.g., an allograft bone dowel
`
`implant) or formed from a combination of artificial material and bone (e.g., a metal cage with
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`bone material therein). See id.; First McAfee Decl. (Ex. 1001), ¶¶ 27-28. In accordance
`
`with the usage of the term “implant” in the ‘997 patent, the term “implant” in the context of
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`spinal fusion was and is broadly understood to include implant structures formed from bone
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`(e.g., an allograft bone dowel implant) or formed from an artificial material. This fact is
`
`consistent with the ‘997 patent specification, which broadly uses the term “implant” to refer
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`to implant structures formed from bone (e.g., an allograft bone dowel implant) or formed
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`from an artificial material. See ‘997 patent (Ex. 1002) at col. 17:23-26 and 43 (“an implant
`
`such as a bone dowel”) and at col. 16:29-30 (“titanium”). However, Dr. Sachs also testified
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`that “fusions of the posterior column are often performed without an implant.” Sachs Decl.
`
`(Ex. 2038), ¶ 30. Although such procedures in the “posterior column” are possible, those
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`procedures are not relevant to any of the Grounds proposed in Petitions for the inter partes
`
`review proceedings IPR2013-00208 and IPR2013-00206, which all rely upon primary
`
`references (such as Jacobson) that target a spinal disc space in the anterior column of the
`
`
`
`4
`
`
`
` 5
`
`
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`spine (like any interbody fusion procedure), not a posterior column outside of the disc
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`space. See First McAfee Decl, Ex. 1001, ¶ 10 (illustrating where the anterior and posterior
`
`columns of the spine are). In other words, although it is possible for bone fusion to occur
`
`without an implant (such as the autofusion that occurs when a broken bone or bones fuse
`
`together without surgical intervention or during some procedures in the posterior column),
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`that is not the type of fusion procedure that is expressly suggested by the Jacobson
`
`reference, and a spinal surgeon of ordinary skill in reviewing the full context of the Jacobson
`
`reference would have readily understood this fact.
`
`5.
`
`In ¶ 33, Dr. Sachs testified that the “direct lateral approach” provides a
`
`pathway that “avoids traversing the major nerve roots that are exiting the spinal cord,” but
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`this is not accurate. For example, the direct lateral approach to the lumbar spine does not
`
`avoid traversing major nerve roots that are exiting the spinal cord and passing through the
`
`psoas muscle. See Moro et al., An anatomic study of the lumbar plexus with respect to
`
`retroperitoneal endoscopic surgery, SPINE Vol. 28 (2003) (Ex. 1073), pp. 423-28 (illustrating
`
`the presence of major nerve roots exiting the spinal cord that often extend across the field of
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`a direct lateral approach to various lumbar levels, and showing that, at a time as late as
`
`2003, “surgeons have not felt comfortable with dissecting the psoas because of the
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`presence of the lumbar plexus”).
`
`6.
`
`In ¶ 41, Dr. Sachs testified that “the methods claimed by the ‘997 and the
`
`resulting placement of the spinal implant is illustrated in Figures 30 and 31 of the ‘997
`
`
`
`5
`
`
`
` 6
`
`
`
`patent.” First, Dr. Sachs was confusing Figure 31 (which shows an anterior insertion of the
`
`implant) with Figure 29 of the ‘997 patent. In other words, according to ¶ 41 of Sachs’
`
`declaration, Figures 29 and 30 (not Figure 31) are identified in the ‘997 patent as showing
`
`implants in a lateral orientation. See Sachs Deposition at 170:17-20 (confirming that it
`
`“should read Figures 29 and 30”). Second, the spinal implant illustrated in Figure 30 (and
`
`its corresponding Figure 29) do not illustrate the methods claimed by claims 24-30 of the
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`‘997 patent, which require an implant that “occup[ies] the full transverse width of the
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`vertebral bodies” (not merely “substantially” the full transverse width) under a literal reading
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`of full transverse width. Any ordinary surgeon with even minimal knowledge of using
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`devices in the human spine would recognize from Figure 30 of the ‘997 patent that the
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`implant I occupies less than the full transverse width of the vertebral bodies, as is plainly
`
`shown by the gaps on the leading and trailing ends of the implant I. See ‘997 patent (Ex.
`
`1002) at FIG. 30; see also Sachs depo. transcript and Ex. 1027 (Dr. Sachs identifying what
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`the “full transverse width of the vertebrae” would be on the diagram of a vertebra shown in
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`the ‘997 patent’s prosecution history, p. 29 of Exhibit 1003). Lastly, to the extent that this
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`testimony in ¶ 41 indicates that only the “lumbar” implant of Figure 30 (and its
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`corresponding Figure 29) illustrate the methods claim in the ‘997 patent (to the exclusion of
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`the “thoracic” implant I as illustrated in Figure 23), such an assumption would ignore both
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`the broadest reasonable interpretation standard and the text of the claims (“human thoracic
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`or lumbar spine”) for the reasons described in more detail below.
`
`
`
`6
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` 7
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`
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`7.
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`In ¶ 42, Dr. Sachs testified that he has “been a practicing surgeon for over 30
`
`years and am not aware of any surgeons who performed a direct lateral interbody implant
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`fusion procedure prior to 1995.” But there were surgeons who had performed direct lateral
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`interbody fusion procedures prior to 1995. First, Dr. Jacobson has testified that he
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`performed such procedures in the 1980s using the techniques described in his ‘374 patent.
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`See March 2014 Jacobson Decl. (Ex. 1030), ¶ 10. Also, other spinal surgeons also
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`performed direct lateral interbody implant fusion procedures using fusion implants in the
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`form of allograft bone dowels (the same type of bone dowel implants contemplated in the
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`‘997 patent (Ex. 1002) at col. 17, lines 23-26 and 43). See First McAfee Decl. (Ex. 1001), ¶
`
`11 and App. B (Crock Affidavit); see also Exhibits 1019, 1020, 1021, 1022, 1023, 1024,
`
`2025 and 1026 in IPR2013-00208, which are the same as Exhibits 1014, 1015, 1016, 1017,
`
`1018, 1019, 1020 and 1021 in IPR2013-00206 (Dr. Crock Affidavit and all attachments
`
`thereto). Further yet, I was part of a group of spine surgeons who performed a study on the
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`“Lateral BAK” procedure wherein the procedures started in 1994, which was reported after
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`the completion of our study in 1998. See 1998 Paper on Lateral BAK, (Ex. 1067). The
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`“Lateral BAK” procedure was a direct lateral interbody implant fusion procedure using the
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`threaded cylindrical Bagby and Kuslich (“BAK”) fusion cage, which was a threaded
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`cylindrical fusion implant marketed by a company called Spine-Tech under a license to the
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`Michelson ‘247 patent. Although our results of our “Lateral BAK” study were not published
`
`until 1998, the fact that we were doing the study was well known within the spinal surgery
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`
`
`7
`
`
`
` 8
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`
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`community. I know that Dr. Sachs was aware of our study at the time it was being done,
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`and he is aware of the 1998 that reports the results of our Lateral BAK study.
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`8.
`
`In ¶ 45, Dr. Sachs testified that, “prior to Dr. Michelson’s invention, surgeons
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`did not have the incentive to perform interbody fusions utilizing the direct lateral approach.”
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`This is also not true. First, other surgeons and I were also incentivized to perform such
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`procedures during the same time prior to 1995. See, supra, ¶ 7. Second, this is also
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`contrary to the express suggestion to try such direct lateral fusion procedures as set forth in
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`Jacobson. See Jacobson (Ex. 1004) at col. 6, lines 9-13; see also March 2014 Jacobson
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`Decl. (Ex. 1030), ¶¶ 4-8. A surgeon having ordinary skill in the art during the early 1990s
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`would have recognized that Jacobson teaches how to provide a direct lateral access
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`cannula 11 suitable for removing disc material (Jacobson FIGS. 6-8) and that Jacobson
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`furthermore provides an explicit motivation or incentive to perform a “fusion” procedure
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`utilizing the direct lateral access cannula 11. See First McAfee Decl. (Ex. 1001), ¶¶ 11 and
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`22.
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`9.
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`Also regarding Dr. Sachs’ testimony in ¶ 45, Dr. Sachs’ conclusions appear to
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`be based on the assumption that surgeons would not perform direct lateral fusion
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`procedures merely because a bone graft implant purportedly could not be harvested “from
`
`the iliac crest” that is long enough for a direct lateral insertion. See Sachs Decl. (Ex. 2038),
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`¶ 45. First, his assumption is not true, especially for the smaller vertebrae in the thoracic
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`spine, which is recited by the claims of the ‘997 patent. Second, Dr. Crock performed actual
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`
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`8
`
`
`
` 9
`
`
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`surgeries in which he harvested a bone dowel “from the iliac crest” for a direct lateral
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`insertion into a lumbar disc space. See Ex. 1023 from IPR2013-00208 (which is Ex. 1018
`
`from IPR2013-00206), Fig. 3 (showing side view of vertebrae with two translateral bone
`
`dowels inserted between the vertebrae); First McAfee Decl. (Ex. 1001), ¶ 11 and Appendix
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`B (Crock Affidavit, ¶¶ 36-42); see also Exhibits 1019-1026 in IPR2013-00208 (which are
`
`Exhibits 1014-1021 in IPR2013-00206) (Crock Affidavit and all attachments thereto).
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`Moreover, a surgeon of ordinary skill in the art during the early 1990s would not have
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`recognized these assumptions in ¶ 45 as a factor that somehow prevented a direct lateral
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`fusion procedure, especially because allograft bone dowels at the time were not limited to
`
`bone harvested merely “from the iliac crest” and because fusion implants during the early
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`1990s were commonly made from artificial materials (again, not limited to bone harvested
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`merely “from the iliac crest”). See, e.g., Brantigan (Ex. 1006) at FIGS. 8 and 10; Michelson
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`‘247 (Ex. 1008) at FIG. 5; Michelson PCT (Ex. 1014 in IPR2013-00208) at FIG. 19.
`
`10.
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`In ¶¶ 46-48, Dr. Sachs states his “belie[f]” that Crock does not disclose a
`
`direct lateral approach. His “belie[f]” here is an allegation that Dr. Crock perjured himself.
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`See First McAfee Decl. (Ex. 1001) at Appendix B (Crock Affidavit, ¶¶ 36-42). Dr. Crock is
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`one of the most revered spinal surgeons alive today, with honors for his spinal surgery work
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`ranging from receiving the Order of Australia (akin to the Presidential Medal of Freedom in
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`the U.S. or Knighthood in the United Kingdom), to becoming an Honorary Fellow of the
`
`Royal College of Surgeons Edinburgh and a Corresponding Fellow of the Japanese
`
`
`
`9
`
`
`
`10
`
`
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`Orthopaedic Association, and to being named to the “Spine Hall of Fame” by the Burton
`
`Report (http://www.burtonreport.com/infspine/HallFameBiosII.htm#Harry). A person of Dr.
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`Crock’s skill and highly respected experience would not make false statements regarding
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`basic facts of anatomy. I disagree with Dr. Sachs’ allegations against Dr. Crock and his
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`article (the Crock reference) for the reasons explained in my first declaration (¶ 11). Dr.
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`Sachs’ discussion of tangential issues regarding a book published ten years later or Dr.
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`Sachs’ apparent confusion between the direct anterior example (FIG. 2) in the Crock article
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`versus the direct lateral example (FIG. 3) in the Crock article do not change the facts of Dr.
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`Crock’s actual surgeries using a direct lateral approach as reported in the Crock article.
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`See Exhibit 1023 from IPR2013-00208 (which is Ex. 1018 from IPR2013-00206). Also, Dr.
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`Sachs’ discussion (¶ 46) of the earlier litigation before the District Court for the Southern
`
`District of California indicates only what the judge understood from Dr. Sachs’ earlier
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`testimony alone without any testimony from Dr. Crock himself, which is different from the
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`evidence in this proceeding. Dr. Sachs appears to be misunderstanding Crock in an effort
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`to reach a (wrong) conclusion that is not only disputed by me but also by Dr. Crock
`
`himself—the surgeon that personally performed the direct lateral surgeries described in
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`Crock. See First McAfee Decl. (Ex. 1001), ¶ 11 and Appendix B (Crock Affidavit, ¶¶ 36-42)
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`see also Exhibits 1019, 1020, 1021, 1022, 1023, 1024, 2025 and 1026 in IPR2013-00208,
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`which are the same as Exhibits 1014, 1015, 1016, 1017, 1018, 1019, 1020 and 1021 in
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`IPR2013-00206 (Dr. Crock Affidavit and all attachments thereto). As described in detail
`
`
`
`10
`
`
`
`11
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`
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`below, Dr. Sachs’ propensity to mischaracterize the work of other spine surgeons is
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`illustrated also by his “belie[f]” in what is disclosed by the Jacobson reference and what is
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`disclosed by the Brantigan ‘327 reference. See March 2014 Jacobson Decl. (Ex. 1030), ¶¶
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`3-10; March 2014 Brantigan Decl. (Ex. 1031), ¶¶ 7-22. Finally, Dr. Sachs testifies (in ¶ 48)
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`that “surgeons did not start performing direct lateral interbody fusion surgeries until after
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`1995.” As previously described above, this statement is inconsistent with the reality that
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`other surgeons and I were performing direct lateral interbody fusion procedures prior to
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`1995 and also during 1995. See, supra, ¶ 7.
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`III. Rebuttal of Dr. Sachs’ testimony regarding conception/reduction to practice
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`11.
`
` In ¶¶50-53, Dr. Sachs discusses evidence regarding Dr. Michelson’s
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`equipment and activity in 1993 and testifies that “Dr. Michelson testified that he conceived
`
`and reduced to practice the ‘997 patent methods no later than August or September 1993.”
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`See Sachs Decl. (Ex. 2038), ¶ 50 (emphasis added). This characterization regarding the
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`testimony from Dr. Michelson is misleading and contradicted by the evidence. First, it is
`
`misleading because the ‘997 patent claims were not even in existence at the time of the
`
`testimony, and the testimony relates to a very different patent claim directed only to an
`
`implant. Dr. Michelson testified in November 2010—more than a year before the ‘997
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`patent claims were initially filed. If the ‘997 patent claims did not exist in November 2010,
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`Dr. Michelson certainly never testified about the methods as specifically recited in ‘997
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`patent claims. Second, this allegation regarding Dr. Michelson’s testimony is inaccurate
`
`
`
`11
`
`
`
`12
`
`
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`because Dr. Michelson testified about a different patent (U.S. Patent No. 5,860,973 or “the
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`‘973 patent”) having a different specification and vastly different claim limitations:
`
`
`
`12
`
`
`
`
`
`13
`
`
`
`Not only are the ‘997 patent claims at issue in this proceeding directed to specific surgical
`
`method steps rather than an “implant” structure of the ‘973 patent claims, but the ‘997
`
`patent claims require multiple different claim limitations that were never contemplated in Dr.
`
`Michelson’s testimony in November 2010 (certainly not in the limited portions cited by Dr.
`
`Sachs in Ex. 2001). This same conclusion is true to a greater degree for the remaining
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`independent claims 9, 17, and 24 of the ‘997 patent, all of which recite even more limitations
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`than claim 1 (reproduced above) that were never part of Dr. Michelson’s testimony about
`
`the ‘973 patent. For example, nothing in the Sachs Declaration or in Ex. 2001 indicates that
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`Dr. Michelson testified about the step of “positioning a single elongated portion removably
`
`attached to said distal end of said third surgical instrument over the disc space” (claim 9),
`
`about the step of “positioning said third surgical instrument such that at least part of one of
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`said at least two elongated portions is over one of the two adjacent vertebrae and at least
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`part of another of said at least two elongated portions is over the other of the two adjacent
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`vertebrae” (claim 17), or about the step of “positioning said third surgical instrument such
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`that the midpoint of the width of said first elongated portion is over the disc space and said
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`second elongated portion is over one of the two adjacent vertebrae and said third elongated
`
`portion is over the other of the two adjacent vertebrae” (claim 24). I have been informed
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`that the Patent Office rules provide the Patent Owner with an opportunity in this proceeding
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`to present testimony from Dr. Michelson specifically regarding the ‘997 patent claims (rather
`
`
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`13
`
`
`
`14
`
`
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`than his older testimony about the different ‘973 patent). I understand that no such
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`testimony from Dr. Michelson has been submitted by Warsaw.
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`12.
`
`In ¶ 51, Dr. Sachs cites to three portions of the November 2010 testimony of
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`Dr. Michelson (Ex. 2001) and then concludes that “[i]n December of 1993, Dr. Michelson
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`demonstrated his lateral spinal implant and instrumentation technology to Mr. Lukianov [now
`
`the CEO of NuVasive].” I have reviewed the cited portions of Ex. 2001, and I find no
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`evidence that confirms Mr. Lukianov was present in the December 1993 meeting when Dr.
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`Michelson demonstrated his equipment. Rather, in the same litigation record, Mr. Lukianov
`
`testified that Dr. Michelson did not show him a lateral approach, nor did they discuss the
`
`lateral approach. Lukianov Trial Testimony (Ex. 1044), 531:22-532:11, 536:6-14; 555:12-
`
`18. Even Dr. Michelson testified that he does not remember Mr. Lukianov being present
`
`while he demonstrated his equipment. Michelson Trial Testimony (Ex. 1043), 193:22-194:3.
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`13.
`
`In ¶ 51, Dr. Sachs relies upon the December 1993 meeting and an invoice
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`from Mr. Imre (a machinist that apparently constructed prototypes) as purported evidence of
`
`the methods claimed in the ‘997 patent (see Exhibits 2001 and 2004), but these items do
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`not demonstrate all method steps recited in claim 1 or any other claim of the ‘997 patent.
`
`First, I agree that Ex. 2004 identifies “an implant with a 42 mm length and a 24 mm
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`diameter,” although I note further that Dr. Sachs also contends that “a 42 mm implant will
`
`occupy the transverse width of vertebral bodies.” Dr. Sachs’s reliance the “42 mm” implant,
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`however, fully supports my analysis that the implant length in Brantigan’s FIG. 10 is likewise
`
`
`
`14
`
`
`
`15
`
`
`
`sufficient to disclose the claim limitation of “sized to occupy substantially the full transverse
`
`width of the vertebral bodies.” See First McAfee Decl. (Ex. 1001), ¶ 29. In particular, the
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`evidence cited by the Patent Owner regarding Dr. Michelson’s “lateral approach to the
`
`spine” indicates that the implant was contemplated for “the lateral spine at L4-5 and L3-4”:
`
`
`
`See Ex. 2005 at p. 8. This same exact page of Ex. 2005 is relied upon by Dr. Sachs for
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`evidence of Dr. Michelson’s conception of the lateral method. See Sachs Decl. (Ex. 2038),
`
`¶ 52. No evidence indicates that Dr. Michelson had contemplated (before his Feb. 27, 1995
`
`patent filing) that his procedure may be used for any other levels of the spine other than the
`
`lower lumbar, L3-L4 or L4-L5. For example, there is no evidence pre-dating the Feb. 27,
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`1995 filing date that shows that Dr. Michelson had contemplated his method for use in the
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`upper lumbar or the thoracic parts of the spine. At the two disc levels described by the
`
`Boyd memo (L4-5 and L3-4), the average transverse width of the vertebral bodies for men
`
`and women (e.g., the superior level of L5 and L4) is roughly 53.4 mm and 51.2 mm,
`
`respectively:
`
`
`
`15
`
`
`
`16
`
`
`
`
`
`See First McAfee Decl. (Ex. 1001) at Appendix C, Berry article at pp. 363-64. The Berry
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`article provided vertebra measurements from 15 men and 15 women. A surgeon having
`
`ordinary skill in the art of spinal surgery would have known during the early 1990s (and
`
`today) that a fusion implant having a length of “42 mm” would occupy only about 78-82% of
`
`the average transverse width of vertebral bodies at the L4-5 and L3-4 disc levels that were
`
`contemplated by Dr. Michelson—a relative value that is consistent with my previous
`
`analysis of Brantigan’s FIG. 10 and with FIG. 23 of the ‘997 patent. See First McAfee Decl.
`
`(Ex. 1001), ¶ 29. Dr. Sachs apparently assumes in ¶ 51 (without citing any support) that the
`
`42 mm implant listed in the Ex. 2004 was demonstrated in “the lower thoracic and upper
`
`lumbar region of spine.” However, nothing in the documents cited by Dr. Sachs shows that
`
`Dr. Michelson in fact demonstrated or used or even contemplated the 42 mm implant for
`
`implantation in “the lower thoracic and upper lumbar region of spine” as implied ¶ 51 of the
`
`Sachs declaration. To the contrary, the only documents cited by Dr. Sachs indicate that the
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`42 mm implant was to be used in “the lateral spine at L4-5 and L3-4” as indicated by the
`
`Boyd memo. Ex. 2005 at p. 8. Also, even if the “42 mm” implant was considered in portions
`
`of the upper lumbar spine (despite there being no evidence showing that was contemplated
`
`before Dr. Michelson’s patent filing in Feb. 27, 1995), the average transverse width of the
`
`vertebral bodies in the upper lumbar region of spine (e.g., the inferior level of L1, the
`
`
`
`16
`
`
`
`17
`
`
`
`superior and inferior levels of L2, and the superior level of L3) ranges between 47.7 and
`
`54.8 mm:
`
`
`
`
`
`See First McAfee Decl. (Ex. 1001) at Appendix C, Berry article at pp. 363-64. As such, the
`
`42 mm implant would be between 85.5% and 76.6% of the average transverse width of the
`
`adjacent vertebral bodies for the upper lumbar levels (L1-2 or L2-3) of the lumbar spine)—
`
`again, a relative value that is consistent with my previous analysis of Brantigan ‘327’s Figure
`
`10 and with Figure 23 of the ‘997 patent. See First McAfee Decl. (Ex. 1001), ¶ 29.
`
`14.
`
`Second, regarding ¶ 51 of the Sachs declaration, I agree that the invoice from
`
`Mr. Imre (Ex. 2004) identifies an outer sleeve “with cap.” Although it is not specifically
`
`stated, the Sachs declaration apparently relies on this cap as meeting the claim limitations
`
`in claim 9 for the “single elongated portion removably attached to said distal end of said
`
`third surgical instrument.” In fact, Dr. Sachs confirmed his reliance on that item for claim 9.
`
`See Sachs Deposition at 163:1-164:15. But, Dr. Sachs also admitted during his deposition
`
`that the Imre invoice (Ex. 2004) provides no description that the “cap” included an
`
`“elongated portion” of any type, and certainly not the “substantially” longer type required for
`
`with Dr. Sachs’ interpretation of this claim element (see, infra, ¶ 24). See Sachs Deposition
`
`at 164:16-20. I also note that nothing indicates that the “cap” mentioned in the Imre invoice
`
`is “removably attached to said distal end” of the outer sleeve, but instead the “cap”
`
`
`
`17
`
`
`
`18
`
`
`
`mentioned in the Imre invoice is more consistent in terminology with, and appears to be a
`
`version of, Dr. Michelson’s “cap” (cap 340) mounted on the proximal end of the outer sleeve
`
`as shown in the ‘997 patent:
`
`
`
`See ‘997 patent (Ex. 1002) at FIG. 20; col. 16:36-40.
`
`15.
`
`Third, regarding ¶ 51 of the Sachs declaration, Dr. Sachs’ admission that the
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`Imre invoice (Ex. 2004) does not describe any “elongated portion” on the outer sleeve is
`
`also relevant to independent claims 17 and 24, each of which require a third surgical
`
`instrument having multiple “elongated portions.” For example, claim 17 requires a “third
`
`surgical instrument having at least two elongated portions” and claim 24 requires a “third
`
`surgical instrument having a first, a second, and a third elongated portion.” Again, Dr. Sachs
`
`relies on the outer sleeve “with cap” in Imre invoice (Ex. 2004) for proof of the claimed “third
`
`surgical instrument,” but Dr. Sachs conceded during his deposition that the Imre invoice (Ex.
`
`2004) provides no description that the “outer sleeve with cap” including an “elongated
`
`portion” of any type, and certainly not multiple elongated portions. See Sachs Deposition at
`
`163:1-20. Dr. Sachs later testified during his deposition that multiple “elongated portions”
`
`
`
`18
`
`
`
`19
`
`
`
`are disclosed in the ALIF and PLIF examples depicted on page 6 of the Boyd memo (Ex.
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`2005). See Sachs Deposition (Ex. 1028) at 167:1-168:8. First, page 6 of the Boyd memo
`
`(Ex. 2005) describes instruments for direct anterior (ALIF) or direct posterior (PLIF
`
`approaches), not the claimed method “along the coronal plane” as recited in claims 17 and
`
`24 of the ‘997 patent. Second, the examples illustrated on page 6 of the Boyd memo do not
`
`describe “three” elongated portions (as required by claim 24) or that any elongated portion
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`of the outer sleeve is positioned “over the disc space” (as required by claim 24). Third, Dr.
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`Sachs’ reliance on page 6 of the Boyd memo is misplaced because the examples on page 6
`
`show that the outer sleeve penetrates into the vertebral bone, but the example on page 8
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`indicates that outer sleeve penetrates into “the disc space” (not the vertebral bone).
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`Compare Ex. 2005 at p. 6, with Ex. 2005 at p. 8. Also, nothing in the Boyd memo (on either
`
`page 6 or page 8) describes that the outer sleeve has a “cap” (as described in the Imre
`
`invoice), and in fact the examples of pages 6 and 8 of the Boyd memo suggest outer
`
`cannulas having structures that are noticeably different from (and would not corroborate in
`
`the eyes of an ordinary spinal surgeon) the “outer sleeve with cap” listed in the Imre invoice.
`
`16.
`
`Fourth, regarding ¶ 51 of the Sachs declaration, I agree that the invoice from
`
`Mr. Imre (Ex. 2004) does not disclose a “guide wire…separately machined by Dr. Imre.”
`
`Thus, the claimed “first surgical instrument” (e.g., a guide wire) is not described in the
`
`invoice from Mr. Imre (Ex. 2004) or in any other documents cited by Dr. Sachs for use with
`
`the 42 mm implant. In fact, nothing the invoice from Mr. Imre (Ex. 2004) indicates that the
`
`
`
`19
`
`
`
`20
`
`
`
`alleged “second surgical instrument” (e.g., the “distractor” listed in the invoice) was
`
`cannulated (i.e., had a central lumen extending through it) so as to have the capability to be
`
`extended over such a guide wire. For example, the “distractor” listed in the invoice from Mr.
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`Imre (Ex. 2004) and the “bullet-nosed distractor” listed in the Boyd memo (Ex. 2005 at p. 8)
`
`appear to be consistent with a version of Michelson’s non-cannulated distractor illustrated in
`
`the Michelson PCT reference (Ex. 1014 in IPR2013-00208):
`
`
`
`See Ex. 2004 (left) and Ex. 1014 at FIG. 4 (right). This similarity between the distractors
`
`shown above is further supported by page 8 of the Boyd memo, which indicates that the
`
`alleged lateral instruments were “very similar to that already developed” but merely larger in
`
`size. See Ex. 2005 at p. 8; compare Boyd memo at p. 2 (steps 3 and 4 describing the
`
`instruments that were already developed), with Michelson PCT (Ex. 1014 in IPR2013-
`
`00208) at FIGS. 4 and 5. No documents cited in the Sachs declaration indicate that the
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`“distractor” listed in the Imre invoice was cannulated so as to receive a guide wire, and Dr.
`
`
`
`20
`
`
`
`21
`
`
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`Sachs further testified that his analysis of the instruments listed in the Imre invoice is not
`
`based on any engineering/prototype drawings or actual samples of those listed instruments.
`
`See Sachs Deposition at 160:3
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